BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4247796 · Received November 13, 2014

    Report

    Report Number
    2520274-2014-14698
    Event Type
    Injury
    Date Received
    November 13, 2014
    Report Date
    October 29, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHEAH, A., TAN, D., CHONG, A., CHEW, W. (2012) VOLAR PLATING FOR UNSTABLE PROXIMAL INTERPHALANGEAL JOINT DORSAL. FRACTURE-DISLOCATIONS. JHS 37A:28-33. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN 1.3 MM MINI PLATES. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHEAH, A., TAN, D., CHONG, A., CHEW, W. (2012) VOLAR PLATING FOR UNSTABLE PROXIMAL INTERPHALANGEAL JOINT DORSAL FRACTURE-DISLOCATIONS. JHS 37A:28-33. THIS WAS A RETROSPECTIVE REVIEW OF VOLAR MINI PLATE AND SCREW FIXATION THAT THE AUTHORS PERFORMED FOR 13 UNSTABLE PROXIMAL INTERPHALANGEAL (PIP) JOINT DORSAL FRACTURE-DISLOCATIONS (DFDS) FROM APRIL 2006 TO APRIL 2010. THERE WERE 11 MEN AND 2 WOMEN WITH AN AVERAGE AGE OF 33 YEARS (RANGE 15-56 YEARS). THE FRACTURES WERE FIXED WITH EITHER A 1.2MM COMPETITOR¿S PLATE OR A 1.3 MM SYNTHES MINI PLATE AND SCREW CONSTRUCT. WHEN SURVEYED IF THEY WERE HAPPY WITH THE OUTCOME OF THEIR TREATMENT, TWO PATIENTS RESPONDED THAT THEY WERE NOT SATISFIED. FOUR PATIENTS HAD LOSS OF MOTION, THREE OF WHOM HAD SECONDARY SURGERY TO IMPROVE MOBILITY. THE THREE PATIENTS WERE (B)(6) YEAR OLD MALE, (B)(6) YEAR OLD FEMALE, AND (B)(6) YEAR OLD MALE. AT 3 TO 8 MONTHS, THE PIP JOINT IN 3 PATIENTS SHOWED DEGENERATIVE CHANGES THAT WERE DEFINED AS EITHER DECREASED JOINT SPACE COMPARED WITH THE INITIAL POSTOPERATIVE RADIOGRAPH OR DEVELOPMENT OF SUBCHONDRAL SCLEROSIS SEEN ON THE LATERAL RADIOGRAPH. THE CHANGES WERE ASSOCIATED WITH MILD PAIN AND DECREASED MOTION IN 2 OF THE 3 PATIENTS. THE ARTICLE DOES NOT DISTINGUISH WHICH MANUFACTURER WAS ASSOCIATED WITH THE COMPLICATIONS. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN 1.3 MM MINI PLATES. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734363 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention